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Vascepa®

EXPERIENCED

in lipid science

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Vascepa®

LIPID SCIENCE

investor relations

welcome

therapeutics to improve cardiovascular health

Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing
therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive
experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids.
Vascepa® (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription.
For more information about Vascepa visit
www.vascepa.com.

Vascepa

The History of Vascepa

Development of Vascepa leveraged Amarin’s extensive experience in lipid sciences and the
potential therapeutic benefits of polyunsaturated fatty acids. Such development challenged
previously established norms to create a potent, yet safe, targeted single ingredient product
in contrast to prior generation omega-3 mixtures and other prescription drugs. The use of
Vascepa is now supported by over 40 granted patents and by FDA designation in 2015 of
Vascepa’s active ingredient as a New Chemical Entity. This means that no prior FDA-approved
drug had the active ingredient contained in Vascepa. Also, no prior drug with icosapent
ethyl was ever characterized for FDA review and approved by the FDA to treat or prevent a
medical condition.

Early stages of Vascepa development included extensive investigation of high quality,
FDA regulated proprietary manufacturing and packaging designed to protect the active
ingredient from damage during the process and through dose administration in patients.
Further study of Vascepa included a broad range of laboratory and clinical studies,
including two successfully completed Phase 3 studies, the MARINE study and the ANCHOR
study, the results of which were published in 2011 and 2012, respectively. The
aggregate cost of developing Vascepa has exceeded $500 million.

In 2012, the FDA approved Vascepa as an adjunct to diet for the reduction of triglycerides
in adult patients with very high triglyceride levels (>500 mg/dL a.k.a.
hypertriglyceridemia). In 2013, Amarin commercially launched Vascepa in the U.S. based
on this initial indication and since then VASCEPA has been the fastest growing drug in
this market segment. Amarin is pursuing commercialization of Vascepa outside the U.S.
through strategic relationships with various companies.

With the completion of the landmark REDUCE-IT™ cardiovascular outcomes study, Amarin
intends to seek broader labeling for Vascepa. The drug may become the first therapy, as
an adjunct to diet, proven to reduce cardiovascular events when used to treat patients
who despite controlled LDL-cholesterol on stable statin therapy have persistent elevated
triglyceride levels and other cardiovascular risk factors. It is this large, unmet
medical need for potentially tens of millions of patients with dyslipidemia which
development of Vascepa has been targeting for many years.

Vascepa is a drug, not a food product

Only Vascepa is a pure, proven and prescription drug consisting of icosapent ethyl, a
proprietary single-molecule medicine derived from a natural source (fish).

Many approved prescription drugs used today had their origins in nature, which
provides an infinite resource for drug development. As examples, Premarin was
derived from horse urine and aspirin was originally extracted from willow bark.

Vascepa is manufactured to FDA drug standards through a purification process
designed to eliminate impurities and protect the active ingredient from damage
starting from the distillation of active ingredient and through dose administration.

Common fish oil is available on retail shelves and online without a prescription as a
dietary supplement. Common fish oil is not Vascepa.

Common fish oil is not an FDA-approved drug and not intended nor proven safe and
effective to treat patients with medical conditions.

Under FDA regulations, fish oil and other dietary supplements are classified as
food – never a prescription drug – and as such does not have the proven safety and
efficacy of a clinically proven pharmaceutical product.

Further, dietary supplements such as common fish oils are not governed by the same
stringent FDA manufacturing regulations as drugs and are not required to be FDA-approved
before consumer use.3,4

The FDA has designated Vascepa as a new chemical entity (NCE). Common fish oil does not
have this distinction.

The NCE designation signifies that Vascepa alone contains a proprietary, single
active molecule not previously characterized for FDA review and not previously
approved by the FDA to treat or prevent a medical condition. Vascepa’s active
ingredient is derived from nature with unique effect.

It is Vascepa’s distinct purity, proprietary manufacturing processes, stability,
clinical effect, safety profile and FDA review & oversight that makes it different
than common fish oil.